Prosthetic heart valve and method

ABSTRACT

A prosthetic heart valve comprises a radially crimpable and radially expandable, net-like, annular support frame and a valve assembly disposed therein, the valve assembly comprising a conduit tapering from an inlet towards an outlet thereof. Some embodiments or the support frame comprise a proximal portion and a distal portion, a diameter of the proximal portion smaller than a diameter of the distal portion. The proximal portion is dimensioned for deployment in an annulus of a native aortic valve and a distal portion for deployment in an ascending aorta. Some embodiments of the conduit comprise a support construction with a three-cusp, crown-shaped cut line, the support construction sutured to the support frame around a bottom portion thereof and around the cut line. A method for using the prosthetic heart valve to replace a defective native aortic valve uses a minimally invasive procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/716,714, filed May 19, 2015, which is a continuation of U.S. patentapplication Ser. No. 14/159,327, filed Jan. 20, 2014, now U.S. Pat. No.9,132,006, which is a continuation of U.S. patent application Ser. No.13/529,909, filed Jun. 21, 2012, now U.S. Pat. No. 8,632,586, which is acontinuation of U.S. patent application Ser. No. 13/168,016, filed Jun.24, 2011, which is a continuation of U.S. patent application Ser. No.11/692,889, filed Mar. 28, 2007, which is a continuation of U.S. patentapplication Ser. No. 10/637,882, filed Aug. 8, 2003, now U.S. Pat. No.7,510,575, which is a divisional of U.S. patent application Ser. No.10/270,252, filed Oct. 11, 2002, now U.S. Pat. No. 6,730,118, which is acontinuation-in-part of U.S. patent application Ser. No. 09/975,750,filed Oct. 11, 2001, now U.S. Pat. No. 6,893,460, the disclosures all ofwhich are incorporated by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates to implantable devices. More particularly,it relates to a valve prosthesis for cardiac implantation or forimplantation in other body ducts.

BACKGROUND OF THE INVENTION

There are several known prosthetic valves that have been previouslydescribed. U.S. Pat. No. 5,411,552 (Andersen et al.), entitled VALVEPROSTHESIS FOR IMPLANTATION IN THE BODY AND CATHETER FOR IMPLANTING SUCHVALVE PROSTHESIS, discloses a valve prosthesis comprising a stent madefrom an expandable cylinder-shaped thread structure comprising severalspaced apices. The elastically collapsible valve is mounted on the stentwith the commissural points of the valve secured to the projectingapices, which prevents the valve from turning inside out. Deployment ofthe valve can be achieved by using an inflatable balloon which in itsdeflated state is used to carry about it the valve structure to itsposition and, when inflated, deploys the stent in position to its finalsize. See, also, U.S. Pat. No. 6,168,614 (Andersen et al.) entitledVALVE PROSTHESIS FOR IMPLANTATION IN THE BODY and U.S. Pat. No.5,840,081 (Andersen et al.), entitled SYSTEM AND METHOD FOR IMPLANTINGCARDIAC VALVES.

In PCT/EP97/07337 (Letac, Cribier et al.), published as WO 98/29057,entitled VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS, there isdisclosed a valve prosthesis comprising a collapsible valve structureand an expandable frame on which the valve structure is mounted. Thevalve structure is composed of a valvular tissue compatible with thehuman body and blood, the valvular tissue being sufficiently supple andresistant to allow the valve structure to be deformed from a closedstate to an opened state. The valvular tissue forms a continuous surfaceand is provided with guiding means formed or incorporated within, theguiding means creating stiffened zones which induce the valve structureto follow a patterned movement in its expansion to its opened state andin its turning back to its closed state. The valve structure can beextended to an internal cover which is fastened to the lower part of thevalve structure to prevent regurgitation.

There are several known methods currently used for replacing aorticvalves and several types of artificial prosthetic devices. Mechanicalvalves are commonly used in several different designs (single and doubleflap) manufactured by well-known companies such as St. Jude, Medtronic,Sulzer, and others. Some of the main disadvantages of these devices are:a need for permanent treatment of anticoagulants, noisy operation, and aneed for a large-scale operation to implant.

There is a wide range of biologically based valves made of naturalvalves or composed of biological materials such as pericardial tissue.These too are made and marketed by well-known companies such as EdwardsLifesciences, Medtronic, Sulzer, Sorin, and others.

Polymer valves are new and are not yet in use, but several companies arein the process of developing such products. A new type of prosthesis isbeing considered, based on artificial polymer materials such aspolyurethane.

The present invention introduces several novel structural designs forimplantable valves. An aspect of the present invention deals with thepossibility of implanting the valve percutaneously, i.e., inserting thevalve assembly on a delivery device similar to a catheter, thenimplanting the valve at the desired location via a large blood vesselsuch as the femoral artery, in a procedure similar to other knowninterventional cardiovascular procedures. The percutaneous deploymentprocedure and device has an impact on the product design in severalparameters, some of which are explained hereinafter.

The percutaneous implantation of medical devices and particularlyprosthetic valves is a preferred surgical procedure for it involvesmaking a very small perforation in the patient's skin (usually in thegroin or armpit area) under local anesthetic and sedation, as opposed toa large chest surgery incision, which requires general anesthesia,opening a large portion of the chest, and cardiopulmonary bypass. Thispercutaneous procedure is therefore considered safer.

The present invention provides a series of new concepts in the field ofaortic valves and other human valves.

SUMMARY OF THE INVENTION

It is therefore thus provided, in accordance with a preferred embodimentof the present invention, a valve prosthesis device suitable forimplantation in body ducts, the device comprising:

a support stent, comprised of a deployable construction adapted to beinitially crimped in a narrow configuration suitable for catheterizationthrough the body duct to a target location and adapted to be deployed byexerting substantially radial forces from within by means of adeployment device to a deployed state in the target location, thesupport stent provided with a plurality of longitudinally rigid supportbeams of fixed length; and

a valve assembly comprising a flexible conduit having an inlet end andan outlet, made of pliant material attached to the support beamsproviding collapsible slack portions of the conduit at the outlet,

whereby when flow is allowed to pass through the valve prosthesis devicefrom the inlet to the outlet the valve assembly is kept in an openposition, whereas a reverse flow is prevented as the collapsible slackportions of the valve assembly collapse inwardly providing blockage tothe reverse flow.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support stent comprises an annular frame.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly has a tricuspid configuration.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly is made from biocompatiblematerial.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the valve assembly is made from pericardial tissue,or other biological tissue.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly is made from biocompatiblepolymers.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the valve assembly is made from materials selectedfrom the group consisting of polyurethane and polyethylene terephthalate(PET).

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly comprises a main body made fromPET (polyethylene terephthalate) and leaflets made from polyurethane.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said support stent is made from nickel titanium.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams are substantially equidistant andsubstantially parallel so as to provide anchorage for the valveassembly.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams are provided with bores so as toallow stitching or tying of the valve assembly to the beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams are chemically adhered to thesupport stent.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly is riveted to the support beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly is stitched to the support beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said beams are manufactured by injection using amold, or by machining.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly is rolled over the support stentat the inlet.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve device is manufactured using forging ordipping techniques.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly leaflets are longer than neededto exactly close the outlet, thus when they are in the collapsed statesubstantial portions of the leaflets fall on each other creating bettersealing.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said valve assembly is made from coils of a polymer,coated by a coating layer of same polymer.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said polymer is polyurethane.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support stent is provided with heavy metalmarkers so as to enable tracking and determining the valve deviceposition and orientation.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the heavy metal markers are selected from gold,platinum, iridium, or tantalum.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the valve assembly leaflets are provided withradio-opaque material at the outlet, so as to help tracking the valvedevice operation in vivo.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said radio-opaque material comprises gold thread.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the diameter of said support stent, when fullydeployed is in the range of from about 19 to about 25 mm.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the diameter of said support stent may be expandedfrom about 4 to about 25 mm.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams are provided with bores and whereinthe valve assembly is attached to the support beams by means of U-shapedrigid members that are fastened to the valve assembly and that areprovided with extruding portions that fit into matching bores on thesupport beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams comprise rigid support beams in theform of frame construction, and the valve assembly pliant material isinserted through a gap in the frame and a fastening rod is insertedthrough a pocket formed between the pliant material and the frame andholds the valve in position.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the main body of the valve assembly is made fromcoiled wire coated with coating material.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the coiled wire and the coating material is made frompolyurethane.

Furthermore, in accordance with another preferred embodiment of thepresent invention, a strengthening wire is interlaced in the valveassembly at the outlet of the conduit so as to define a fault line aboutwhich the collapsible slack portion of the valve assembly may flap.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the strengthening wire is made from nickel titaniumalloy.

Furthermore, in accordance with another preferred embodiment of thepresent invention, there is provided a valve prosthesis device suitablefor implantation in body ducts, the device comprising a main conduitbody having an inlet and an outlet and pliant leaflets attached at theoutlet so that when a flow passes through the conduit from the inlet tothe outlet the leaflets are in an open position allowing the flow toexit the outlet, and when the flow is reversed the leaflets collapse soas to block the outlet, wherein the main body is made from PET andcollapsible leaflets are made form polyurethane.

Furthermore, in accordance with another preferred embodiment of thepresent invention, support beams made from polyurethane are provided onthe main body and wherein the leaflets are attached to the main body atthe support beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, said support beams are chemically adhered to the mainbody.

Furthermore, in accordance with another preferred embodiment of thepresent invention, there is provided a valve prosthesis device suitablefor implantation in body ducts, the device comprising:

a support stent, comprised of a deployable construction adapted to beinitially crimped in a narrow configuration suitable for catheterizationthrough the body duct to a target location and adapted to be deployed byexerting substantially radial forces from within by means of adeployment device to a deployed state in the target location, thesupport stent provided with a plurality of longitudinally rigid supportbeams of fixed length;

a valve assembly comprising a flexible conduit having an inlet end andan outlet, made of pliant material attached to the support beamsproviding collapsible slack portions of the conduit at the outlet; and

substantially equidistant rigid support beams interlaced or attached tothe slack portion of the valve assembly material, arrangedlongitudinally.

Furthermore, in accordance with another preferred embodiment of thepresent invention, there is provided a crimping device for crimping thevalve device described above or in claim 1, the crimping devicecomprising a plurality of adjustable plates that resemble a typical SLR(Single Lens Reflex) camera variable restrictor, each provided with ablade, that are equally dispersed in a radial symmetry but each platemoves along a line passing off an opening in the center, all platesequidistant from that center opening.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the multiple plates are adapted to movesimultaneously by means of a lever and transmission.

Furthermore, in accordance with another preferred embodiment of thepresent invention, there is provided a method for deploying animplantable prosthetic valve device from the retrograde approach(approaching the aortic valve from the descending aorta) or from theantegrade approach (approaching the aortic valve from the left ventricleafter performing a trans-septal puncture) at the natural aortic valveposition at the entrance to the left ventricle of a myocardium of apatient, the method comprising the steps of:

(a) providing a balloon catheter having a proximal end and a distal end,having a first and second independently inflatable portions, the firstinflatable portion located at the distal end of the catheter and thesecond inflatable portion adjacently behind the first inflatableportion;

(b) providing a guiding tool for guiding the balloon catheter in thevasculature of the patient;

(c) providing a deployable implantable valve prosthesis device adaptedto be mounted on the second inflatable portion of the balloon catheter;

(d) for the retrograde approach, guiding the balloon catheter throughthe patient's aorta using the guiding tool, the valve device mountedover the second inflatable portion of the balloon catheter until thefirst inflatable portion of the balloon catheter is inserted into theleft ventricle, whereas the second inflatable portion of the ballooncatheter is positioned at the natural aortic valve position;

(e) for the antegrade approach, guiding the balloon catheter through thepatient's greater veins, right atrium, left atrium, and left ventricleusing the guiding tool, the valve device mounted over the secondinflatable portion of the balloon catheter until the first inflatableportion of the balloon catheter is inserted into the left ventricle,whereas the second inflatable portion of the balloon catheter ispositioned at the natural aortic valve position;

(f) inflating the first inflatable portion of the balloon catheter so asto substantially block blood flow through the natural aortic valve andanchor the distal end of the balloon catheter in position;

(g) inflating the second inflatable portion of the balloon catheter soas to deploy the implantable prosthetic valve device in position at thenatural aortic valve position;

(h) deflating the first and second inflatable portions of the ballooncatheter; and

(i) retracting the balloon catheter and removing it from the patient'sbody.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the guiding tool comprises a guide wire.

Furthermore, in accordance with another preferred embodiment of thepresent invention, there is provided a method for deploying animplantable prosthetic valve device at the natural aortic valve positionat the entrance to the left ventricle of a myocardium of a patient, themethod comprising the steps of:

(a) providing a balloon catheter having a proximal end and a distal end,having a first and second independently inflatable portions, the firstinflatable portion located at the distal end of the catheter and thesecond inflatable portion adjacently behind the first inflatableportion;

(b) providing a guiding tool for guiding the balloon catheter in thevasculature of the patient;

(c) providing a deployable implantable valve prosthesis device adaptedto be mounted on the first inflatable portion of the balloon catheter,and a deployable annular stent device adapted to be mounted over thesecond inflatable portion of the balloon catheter, the deployableimplantable valve prosthesis device and the deployable annular stentkept at a predetermined distant apart;

(d) guiding the balloon catheter through the patient's aorta using theguiding tool, the valve device mounted over the first inflatable portionof the balloon catheter and the deployable annular stent mounted overthe second inflatable portion of the balloon catheter, until the firstinflatable portion of the balloon catheter is positioned at the naturalaortic valve position;

(e) inflating the second inflatable portion of the balloon catheter sothat the deployable stent device is deployed within the aorta thusanchoring the deployable annular stent and the coupled valve device inposition;

(f) inflating the first inflatable portion of the balloon catheter so asto deploy the implantable prosthetic valve device in position at thenatural aortic valve position;

(g) deflating the first and second inflatable portions of the ballooncatheter; and

(h) retracting the balloon catheter and removing it from the patient'sbody.

Furthermore, in accordance with another preferred embodiment of thepresent invention, a valve prosthesis device suitable for implantationin body ducts comprises:

an expandable support frame, the support frame provided with a pluralityof longitudinally rigid support beams of fixed length; and

a valve assembly comprising a flexible conduit having an inlet end andan outlet, made of pliant material attached to the support beamsproviding collapsible slack portions of the conduit at the outlet,

whereby when flow is allowed to pass through the valve prosthesis devicefrom the inlet to the outlet the valve assembly is kept in an openposition, whereas a reverse flow is prevented as the collapsible slackportions of the valve assembly collapse inwardly providing blockage tothe reverse flow.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support frame comprises a deployable constructionadapted to be initially crimped in a narrow configuration suitable forcatheterization through the body duct to a target location and adaptedto be deployed by exerting substantially radial forces from within bymeans of a deployment device to a deployed state in the target location.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams have a U-shaped cross section.

Furthermore, in accordance with another preferred embodiment of thepresent invention, a holder is used to secure the plaint material to thesupport beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support frame comprises three segments that forma circular assembly when assembled.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams point inwardly with respect to acentral longitudinal axis of the device.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the device is further provided with a restrictingtapered housing, for housing it in a crimped state.

Furthermore, in accordance with another preferred embodiment of thepresent invention, hooks are provided to secure the device in positionafter it is deployed.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams comprise longitudinal bars having anarrow slit used as the commissural attachment so that extensions thepliant material are tightly inserted through it.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the extensions of the pliant material are wrappedabout rigid bars serving as anchorage means.

Furthermore, in accordance with another preferred embodiment of thepresent invention, extensions of the pliant material are sutured to eachother at the rigid bars.

Furthermore, in accordance with another preferred embodiment of thepresent invention, a bottom portion of the pliant material is attachedto the inlet.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support beams are each provided with a roundedpole, forming a loop through which the pliant material is inserted.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the pliant material is provided with longitudinalbars attached to the pliant material at positions assigned forattachment to the support frame, in order to prevent localized stressfrom forming.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the device is further provided with longitudinal barshaving protrusions that are inserted in bores in the pliant material, asheet of PET and through bores provided on the support beams.

Furthermore, in accordance with another preferred embodiment of thepresent invention, pliant material is sutured leaving the slack portionsfree of sutures.

Furthermore, in accordance with another preferred embodiment of thepresent invention, a connecting member with a split portion is used toconnect leaflets of the pliant material to the support beams, the splitconnecting member compressing the pliant material in position.

Furthermore, in accordance with another preferred embodiment of thepresent invention, a portion of the connecting member is perpendicularto the split portion.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support frame is provided with metallic memberscoupled to the stent and rigid members are positioned on two oppositesides of the metallic member and held against each other holding portionof the pliant material between them, sutured, the metallic memberswrapped with PET.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the device is further provided with spring in orderto reduce wear of the pliant material.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the spring is provided with a spiral.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the spring is made from stainless steel.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the spring is attached to slots provided on thesupport frames.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the pliant material is sutured to the support frameforming pockets.

Furthermore, in accordance with another preferred embodiment of thepresent invention, attachment bars are provided on the stent support ata portion of the stent close to the outlet, onto which the pliantmaterial is coupled, and wherein the pliant material is attachedcircumferentially to the inlet, leaving slack pliant material.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the outlet is tapered with respect to the inlet.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support frame at the outlet is wider in diameterthan the pliant material forming the outlet.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the pliant material is reinforced using PET.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the support frame is a tube having an inner wall,having sinusoidal fold lines, wherein the pliant material is sutured tothe inner wall of the tube along suture lines.

Furthermore, in accordance with another preferred embodiment of thepresent invention, additional piece of PET is added below the suturelines.

Furthermore, in accordance with another preferred embodiment of thepresent invention, the device is incorporated with an angioplastyballoon.

Finally, in accordance with another preferred embodiment of the presentinvention, balloon has a central longitudinal axis that runs along aflow path through the device, and a perimeter, the balloon comprisingfour inflatable portions, one portion located along a central axis andthe other three located on the perimeter, the pliant material in theform of leaflets is distributed about the perimeter.

BRIEF DESCRIPTION OF THE FIGURES

To better understand the present invention and appreciate its practicalapplications, the following Figures are provided and referencedhereafter. It should be noted that the Figures are given as examplesonly and in no way limit the scope of the invention as defined in theappended claims.

FIG. 1 illustrates an implantable prosthetic tricuspid valve inaccordance with a preferred embodiment of the present invention,suitable for percutaneous deployment using a stent or similar deployingmeans, in its deployed-inflated position;

FIG. 2 depicts an implantable valve according to the present inventionmounted over a deploying stent with an inflatable balloon;

FIG. 3 illustrates an implantable valve according to the presentinvention mounted over a stent with an inflatable balloon, in a crimpedposition;

FIG. 4 depicts implantable valve deployment in a natural aortic valveposition in accordance with the present invention;

FIG. 5 demonstrates manufacturing a polyurethane implantable valve usinga dipping technique according with the present invention;

FIGS. 6 a to 6 e illustrate manufacturing of an implantable valve byforging according to the present invention;

FIGS. 7 a and 7 b demonstrate composite valve, which has polyurethane(PU) leaflets and PET tubular-crown shaped construction, according tothe present invention;

FIGS. 8 a and 8 b depict a manufacture process of a composite valve madeof flexible PU leaflets, rigid PU construction for mounting and a PETtubular end;

FIGS. 9 to 9 i demonstrate different methods of attachment between thevalve and stent according to the present invention;

FIG. 10 illustrates a dipping mandrel with an extra portion, whichimproves the sealing ability of the valve, according to the presentinvention;

FIG. 11 a to 11 c illustrate a valve mounted on a stent with an extrasupport, which improves the force distribution on the valve material andfacilitates prolonged durability of the valve, according to the presentinvention;

FIGS. 12 a to 12 c depict a valve with rigid supports according to thepresent invention, located substantially in the center of its leaflets.This design allows the valve leaflets to perform without outer support;

FIGS. 13 a to 13 c illustrate the manufacturing of a reinforced PU tubecomposed of strong fiber from PU, PET or other and a softer PU coating,for serving as the supporting structure;

FIGS. 14 and 14 a to 14 c demonstrate incorporation of heavy metalmarkers on the stent, according to the present invention. These markersallow orientation control while positioning the device at the requiredlocation;

FIGS. 15 a to 15 c demonstrate a valve with radio-opaque coating,according to the present invention, which allows imaging of the valvemotion under angiogram;

FIGS. 16 a to 16 c illustrate a procedure, which helps in accuratepositioning the valve device with respect to the longitudinalorientation;

FIGS. 17 a and 17 b describe a valve device according to the presentinvention, comprising one valve assembly mounted on a stent and anadditional portion with a stent only. This allows placing the device ina way that coronaries are not blocked, longitudinal positioning thusbecomes less sensitive and the extra stent decreases the risk of devicemigration within the vasculature;

FIGS. 18 a and 18 b demonstrate a crimping device according to thepresent invention, which can crimp a valve device in the operatingtheater as part of the implantation procedure;

FIGS. 19 a to 19 c depict a crimping machine according to the presentinvention, similar to the one described in FIG. 18 with a differentmechanical method;

FIGS. 20 a and 20 b demonstrate a valve according to the presentinvention, made of a tube mounted on a stent. During systole the tube isfully open and during diastole the tube collapses according to themounting geometry providing tight sealing;

FIG. 21 depicts a stent structure according to the present invention,with built-in mounting portions of constant length, which allow valvemounting;

FIG. 22 depicts yet another preferred embodiment a valve assembly inaccordance with the present invention, having dilated supports;

FIGS. 23 a to 23 e depict stages in a method of manufacturing animplantable prosthetic valve in accordance with another preferredembodiment of the present invention;

FIGS. 24 a to 24 c illustrate a support frame of an implantableprosthetic valve having means for mounting valve leaflets in accordancewith a preferred embodiment of the present invention that can form atricuspid valve. FIG. 24 a depicts an isometric view of the frame, and

FIG. 24 b depicts a cross-sectional view of the means for mounting avalve leaflet in details, provided with a valve leaflet. FIG. 24 cdepicts further details of attachment means for the attachment method;

FIGS. 25 a to 25 d illustrate an implantable prosthetic valve inaccordance with another preferred embodiment of the present invention.FIGS. 25 a and 25 b depict an isometric view and an upper view of thevalve assembly, respectively, and FIGS. 25 c and 25 d illustrate upperviews of two optional constructions for the means for mounting leaflets;

FIGS. 26 a to 26 c illustrate a tricuspid valve in accordance with yetanother preferred embodiment of the present invention, provided with aself-expandable frame. FIG. 26 a is the valve in its fully expandeddiameter, FIG. 26 b is a tapered tool which assists in inserting thevalve into an introducing tube, and FIG. 26 c shows the valve assemblyinside a restriction tube, ready to be inserted into a introducingsheath;

FIG. 27 illustrates an isometric view of an implantable prosthetic valvein accordance with another preferred embodiment of the present inventionhaving hooks designated to anchor the valve assembly to body ducts;

FIG. 28 illustrates a partial view of an implantable prosthetic valve inaccordance with yet another preferred embodiment of the presentinvention. The commissural attachment is showed in details;

FIGS. 29 a and 29 b illustrate an isometric view and an uppercross-sectional view, respectively, of an attachment assembly of avalve's frame to leaflets in accordance with a preferred embodiment ofthe present invention;

FIGS. 30 a to 30 c illustrate an isometric view, a cross-sectional viewand a flattened view, respectively, of an attachment assembly of avalves frame to leaflets in accordance with another preferred embodimentof the present invention. FIG. 30 c is a side view showing two pieces ofpericardium before the attachment to the frame;

FIGS. 31 a and 31 b illustrate an exploded view and an isometric view,respectively, of a commissural attachment in accordance with a preferredembodiment of the present invention depicting the attachment technique;

FIGS. 32 a through 32 c illustrate an isometric view of an attachmentbetween leaflets and the frame in accordance with yet another preferredembodiment of the present invention;

FIGS. 33 a to 33 d illustrate different views and portions of anattachment between a pericardium and a frame in accordance with yetanother preferred embodiment of the present invention, demonstratinganother method of attachment in accordance with the preferredembodiment;

FIGS. 34 a to 34 c illustrate an isometric view of an attachment betweena pericardium and a valve in accordance with yet another preferredembodiment of the present invention demonstrating another method ofattachment. In FIGS. 34 b and 34 c, a deployed portion and the foldedportion, respectively, are shown;

FIGS. 35 a to 35 c illustrate an isometric and cross-sectional upperviews, respectively, of attachment techniques between a pericardiumleaflet and a valve's frame in accordance with another preferredembodiment of the present invention;

FIGS. 36 a and 36 b illustrate an isometric view of a commissuralassembly in accordance with a preferred embodiment of the presentinvention demonstrating a method of forming one;

FIGS. 37 a to 37 c illustrates a commissural assembly in accordance withanother preferred embodiment of the present invention, where theconnecting bar functions as a flexible support and has integralattachment means to the frame. FIG. 37 b is an isometric view of theconnecting bar;

FIGS. 38 a to 38 g illustrate isometric views of flexible commissuralsupports and the method of attaching them to a pericardium and a frameand valve in accordance with preferred embodiments of the presentinvention;

FIGS. 39 a and 39 b illustrate an isometric view of a commissuralattachment in accordance with yet another preferred embodiment of thepresent invention, demonstrating the attachment of the pericardium tothe support by means of a shaped compressing member;

FIGS. 40 a to 40 c illustrate an isometric view of a bicuspid valvemounted on a frame in accordance with yet another preferred embodimentof the present invention. FIGS. 40 b and 40 c depicts a cross-sectionalside view and an isometric view, respectively, of the pericardium thatis sutured to a PET tube in the form of pockets;

FIGS. 41 a to 41 d illustrate isometric views of an implantableprosthesis tricuspid valve in accordance with yet another preferredembodiment of the present invention;

FIGS. 42 a and 42 b illustrate an isometric view of an implantableprosthetic valve in accordance with yet another preferred embodiment ofthe present invention, having a different commissural attachment. FIG.42 b depicts the attachment in details;

FIGS. 43 a and 43 b illustrate an isometric view of an implantableprosthetic valve in accordance with yet another preferred embodiment ofthe present invention. FIG. 43 a depicts the commissure that arepre-sutured in a tapered shape;

FIGS. 44 a to 44 c illustrate an isometric view of an implantableprosthetic valve in accordance with yet another preferred embodiment ofthe present invention, with additional pieces of PET used for sealingand protecting the pericardium;

FIGS. 45 a to 45 d illustrate an isometric view of an implantableprosthetic valve in accordance with yet another preferred embodiment ofthe present invention, having leaflets sutured to a pre-shaped PET tubeand optional leaflet-tube attachments in details;

FIGS. 46 a and 46 b illustrate an exploded view and an uppercross-sectional view of an implantable prosthetic valve assembly inaccordance with yet another preferred embodiment of the presentinvention;

FIGS. 47 a to 47 c illustrate a partial cross-sectional side view of aninflating balloon in accordance with a preferred embodiment of thepresent invention. The balloon is a part of an implantable prostheticvalve delivery system. FIGS. 47 b and 47 c are cross sectional upperviews in the inflated and deflated positions, respectively; and

FIGS. 48 a and 48 b illustrate a partial cross-sectional side view andan upper cross-sectional view of an inflating balloon in accordance withanother preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

A main aspect of the present invention is the introduction of severalnovel designs for an implantable prosthetic valve. Another aspect of thepresent invention is the disclosure of several manufacturing methods forimplantable prosthetic valves in accordance with the present invention.A further aspect of the present invention is the provision of noveldeployment and positioning techniques suitable for the valve of thepresent invention.

Basically the implantable prosthetic valve of the present inventioncomprises a leafed-valve assembly, preferably tricuspid but not limitedto tricuspid valves only, consisting of a conduit having an inlet endand an outlet, made of pliant material arranged so as to presentcollapsible walls at the outlet. The valve assembly is mounted on asupport structure such as a stent adapted to be positioned at a targetlocation within the body duct and deploy the valve assembly by the useof deploying means, such as a balloon catheter or similar devices. Inembodiments suitable for safe and convenient percutaneous positioningand deployment the annular frame is able to be posed in two positions, acrimped position where the conduit passage cross-section presented issmall so as to permit advancing the device towards its target location,and a deployed position where the frame is radial extended by forcesexerted from within (by deploying means) so as to provide supportagainst the body duct wall, secure the valve in position and open itselfso as to allow flow through the conduit.

The valve assembly can be made from biological matter, such as a naturaltissue, pericardial tissue or other biological tissue. Alternatively,the valve assembly may be made form biocompatible polymers or similarmaterials. Homograph biological valves need occasional replacement(usually within 5 to 14 years), and this is a consideration the surgeonmust take into account when selecting the proper valve implant accordingto the patient type. Mechanical valves, which have better durabilityqualities, carry the associated risk of long-term anticoagulationtreatment.

The frame can be made from shape memory alloys such as nickel titanium(nickel titanium shape memory alloys, or NiTi, as marketed, for example,under the brand name Nitinol), or other biocompatible metals. Thepercutaneously implantable embodiment of the implantable valve of thepresent invention has to be suitable for crimping into a narrowconfiguration for positioning and expandable to a wider, deployedconfiguration so as to anchor in position in the desired targetlocation.

The support stent is preferably annular, but may be provided in othershapes too, depending on the cross-section shape of the desired targetlocation passage.

Manufacturing of the implantable prosthetic valve of the presentinvention can be done in various methods, by using pericardium or, forexample, by using artificial materials made by dipping, injection,electrospinning, rotation, ironing, or pressing.

The attachment of the valve assembly to the support stent can beaccomplished in several ways, such as by sewing it to several anchoringpoints on the support frame or stent, or riveting it, pinning it,adhering it, or welding it, to provide a valve assembly that is cast ormolded over the support frame or stent, or use any other suitable way ofattachment.

To prevent leakage from the inlet it is optionally possible to roll upsome slack wall of the inlet over the edge of the frame so as to presentrolled-up sleeve-like portion at the inlet.

Furthermore, floating supports may be added to enhance the stability ofthe device and prevent it from turning inside out.

An important aspect of certain embodiments of the present invention isthe provision of rigid support beams incorporated with the support stentthat retains its longitudinal dimension while the entire support stentmay be longitudinally or laterally extended.

The aforementioned embodiments as well as other embodiments,manufacturing methods, different designs and different types of devicesare discussed and explained below with reference to the accompanyingdrawings. Note that the drawings are only given for the purpose ofunderstanding the present invention and presenting some preferredembodiments of the present invention, but this does in no way limit thescope of the present invention as defined in the appended claims.

Reference is now made to FIG. 1, which illustrates a general tricuspidimplantable prosthetic valve 20 in accordance with a preferredembodiment of the present invention, suitable for percutaneousdeployment using an expandable stent or similar deploying means, shownin its deployed position. A valve assembly 28 comprises a conduit havingan inlet 24 and an outlet 26, the outlet walls consisting of collapsiblepliant material 29 that is arranged to collapse in a tricuspidarrangement. The valve assembly 28 is attached to an annular supportstent 22, the one in this figure being a net-like frame designed to beadapted to crimp evenly so as to present a narrow configuration and beradially deployable so as to extend to occupy the passage at the targetlocation for implantation in a body duct. Support beams 23 are providedon annular support stent 22 to provide anchorage to valve assembly 28.Support beams 23 are optionally provided with bores 25 to allowstitching of valve assembly 28 to support beams 23 by thread, wires, orother attachment means.

In the embodiment shown in FIG. 1, a cuff portion 21 of the valveassembly 28 is wrapped around support stent 22 at inlet 24 to enhancethe stability. Preferably cuff portion 21 of valve material 28 isattached to support beams 23.

Note that the entire valve structure is adapted to be radially crimpedand radially expanded, and this lends to provide ease of navigationthrough narrow passages in the vasculature during positioning of thedevice and adequate deployment on the final location. This is madepossible by the provision of a collapsible support stent structure.However, the support beams remain at all times constant at their lengthand thus are suitable for serving as the pliable valve assembly'sanchorage. The valve assembly is attached to the support stent at thesupport beams, and due to their constant length there is no need forslack material as the attachment points (25) remain at constantdistances regardless of the position of the valve device (crimped ordeployed). This is an important feature for this means that themanufacturer of the valve device can make sure the valve assembly issecured and fastened to the support stent at all times. In prior artimplantable valve devices the entire support structure changes itsdimensions from its initial first crimped position and final deployedposition, and this means that in the attachment of the valve assembly tothe support structure one must take into consideration these dimensionchanges and leave slack material so that upon deployment of the devicethe valve assembly does not tear or deform. In the valve device of thepresent invention there is no relative movement between the valveassembly and the support beams (along the longitudinal central axis ofthe device). As a result, the valve device of the present inventionacquires greater durability and is capable of withstanding the harshconditions prevailing within the vasculature and especially the millionsof cycles of stress applied by the blood pressure.

The fixed attachment of the valve assembly to the support stent in thevalve device of the present invention results in greater stability,enhanced safety, better sealing and consequently longer lifespan. Thenovel design of the valve device of the present invention leads tolongitudinal strength and rigidity whereas its collapsible supportstructure results in radial flexibility.

FIG. 2 depicts an implantable valve 30 mounted on a deployable stent 32.The valve assembly 34 is attached to the deployable support stent 32(dotted lines) along three substantially equidistant and substantiallyparallel support beams 40 of constant length, which are part of stent32. The attachment of valve assembly 34 to stent 32 is facilitated bythe support beams 40 to which valve assembly 34 is stitched with threador fiber 46 (through bores 42 of support beams 40). Outlet leafs 38,which are a slack portion of the valve assembly, dangle inwardly, andthe whole device is carried by an inflatable balloon 48, which serves asthe deploying device. A portion of the valve assembly 34 at an inletzone 45 is optionally rolled over support stent 32 at the inlet, makingup a rolled sleeve, which enhances the sealing of the device at thevalve inlet.

FIG. 3 demonstrates an implantable valve mounted to a stent 50 with aninflatable balloon 52, in a crimped position. The support stent 50 isinitially crimped about the balloon 52 so that is presents a narrowcross-section and is thus suitable for percutaneous catheterization anddeployment.

FIG. 4 depicts an implantable valve deployment in a natural aortic valveposition. The implantable valve is advanced while mounted over theballoon 52 until it reaches the desired target location 54 in a bodyduct, for example, aorta 56. The balloon is inflated and the supportstent 50 expands radially to take up its position.

FIG. 5 demonstrates the manufacture of a polyurethane valve in a dippingtechnique. A dipping mandrel 60 is provided with a tubular portion 62with surfaces 64 that correspond to the collapsible valve leaflets to bemanufactured. Mandrel 60 is dipped into a dissolved polyurethane bath 66and is coated with a polyurethane coating in the desired form of thevalve. Then, after the polyurethane coating has hardened sufficiently,the completed valve is removed from mandrel 60.

FIGS. 6 a to 6 e illustrate manufacturing an implantable valve byforging. A suitable tubularly shaped material 74 is placed tightly on atubular portion 68 of mandrel 67, covering the cusp portion 69. Flexibleinserts 76 are pressed to mandrel 67, forging the tubular material tomandrel shape 80. A tapered ring 70 holds the flexible inserts in placeas the whole mold is placed in a hot oven regulated to a desiredtemperature, which is lower than the material's melting point. FIG. 6 eillustrates a sectional side view of the mandrel and a cross cut portionof the mold. The mold is made to press inwardly on the mandrel, which iscovered with the valve material. As a result the material takes up thedesired shape. The materials used can vary, for example, polyurethane(PU), polyethylene terphthalate (PET), or any other suitable material,which may be formed by heating.

FIGS. 7 a and 7 b demonstrate a method of manufacturing a compositevalve, which has PU leaflets and PET tubular construction with a crownshape. PU is an excellent fatigue resistant material but is sensitive totear. The PU is reinforced by the PET crown to allow safe attachment toa stent by means of stitching, riveting, or any other suitableattachment method. A PET crown 86 is placed on a mandrel 87, which isthen (turned and) dipped in a container of dissolved PU. Themanufactured device is a valve assembly having leaflets 88 composed ofpure PU, and thus fatigue resistant, and a main body made of PET withprotruding attachment portions 90 suitable for attachment built in thePU.

FIGS. 8 a and 8 b demonstrate a method of manufacturing a compositevalve, which is based on flexible PU 92 for as the main body of thevalve, rigid PU support beams 94 serving for the attachment area, andPET sleeve 96 portions for the valve inlet. The need for a rigid portionfor attachment (support beams 94) is explained by the tendency of theflexible, fatigue resistant material to tear as already explained. Theadvantage of the stiff PU support beams is that they are chemicallyadhered to the main body, and this improves the overall durability ofthe valve due to reduction of inner forces and friction in theattachment area specially attachment between two different materials.The valve is dipped in the method mentioned with reference to FIG. 5,and the rigid PU support beam 94 is created by way of mold injection,machining or any other suitable way. The rigid PU support beam 94 isplaced on the valve and then dipped into the container of dissolved PU.This is done while the valve is positioned on the mandrel (not shown).This method provides the ability to composite several materials into onebody and, by that, gain the advantage of the various properties of thematerials as they are needed in different areas of the prosthesis.

FIGS. 9 to 9 i demonstrate different methods of attachment between avalve assembly and the support stents. A valve assembly 99 shown in FIG.9 is incorporated into valve 100 shown in FIG. 9 a, where a supportstent 102 is attached to valve assembly 99 through support beam 106. Adetail is shown in FIG. 9 b, where, in cross-section, it can be seenthat layer 108 is an optional inner support made of stainless steel orrigid polymeric material, valve assembly 99 comprises a PET layer 105coated with a PU layer 104, with the outer support beam 106. Connector107 is a connecting wire made of a strong material, such as stainlesssteel. FIG. 9 c illustrates an alternative arrangement for attachment bya rivet 109, and in FIG. 9 d the attachment is achieved by a suture 110.

FIGS. 9 e to 9 g show an attachment method comprising shaped rigidmembers 116, preferably made from metal, which tightly hold the PU valvematerial 118 by fitting in between a PU U-shaped nest 120 and areattached to a stent 122 by extruding portions 124 that are provided onU-shaped rigid member 116, which fit the bores 126 of the support beam128 of the stent 122. FIGS. 9 h and 9 i show another attachment method,where rigid support beams in the form of frame construction 132 areprovided, and the valve assembly pliant material 135 made of a tubularmaterial is inserted through a gap 137 in the frame. After insertion, afastening rod 133 is inserted through the pocket formed between thepliant material and the frame and holds the valve in position.

FIG. 10 illustrates a dipping mandrel 139 with an extending portion 141,which improves the sealing ability of the valve. Since the valve isattached to a collapsible stent and is itself collapsible, it isdifficult to determine the exact shape of the valve after crimping anddeploying. It is of major importance that sealing will be achieved. Byadding the extension 141 the leaflets are made longer than needed toexactly close the outlet, and therefore when they are in the collapsedstate, substantial portions of the leaflets fall on each other creatingbetter sealing.

FIGS. 11 a to 11 c illustrate a valve assembly mounted on a supportstent 144 with interlaced strengthening wire 146, which improves theforce distribution on the valve material and facilitates prolongeddurability of the valve. The support is in the form of a wire, which hasa crown shape as the shape of the three cusp valve base 148, it also hasthe ability to be crimped 150 to a small diameter, together with thestent, valve and balloon, as shown in FIG. 11 b. The forces applied tothe valve edge 148 while working, are applied to the attachment points,by making the attachment line longer we reduce the force on eachattachment point. In this support method the valve is attached bysuturing 152 the entire line to the extra support wire 146. This wirecan be made of stainless steel, nickel titanium alloy such as nitinol,or polymeric material. The support suture renders the valve assemblydefault fault lines where the valve material more readily flexes, thusensuring proper operation of the valve flaps (leaflets). Optionally thevalve assembly shown in FIGS. 11 a to 11 c can be mounted on a supportstent such as the one described herein or similar supporting structures.The strengthening wire is interlaced in the valve assembly at the outletof the conduit so as to define a fault line about which the collapsibleslack portion 154 of the valve assembly may flap.

FIGS. 12 a to 12 c depict a valve device provided with a stent 159 andsubstantially equidistant rigid support beams 160, interlaced orattached to the slack portion of the valve assembly material 161,arranged longitudinally. This design allows the valve leaflets toperform without outer support. The support in standard valves is bytying the upper edge of the cusp to a rigid embodiment, so that itreacts to the load as a suspension bridge. In this new design theprevention of collapsing is achieved similar to an Indian tent, i.e.,the rigid supports lean on each other 162 when the valve is closed butdo not interfere in opening 164 when the valve is open.

FIGS. 13 a to 13 c illustrate the manufacturing of a valve assembly inaccordance with another preferred embodiment of the present invention.At first a polyurethane thread line 170 is fed from a PU supply 172, andcoiled around a cylindrical drum 174 to form coil 176. Then, drum 174with coil 176 is dipped in a PU bath 177, and a second layer 178 of thePU coats coil 176, making it a stronger construction capable ofwithstanding tearing forces both laterally and in other directions.Incorporating two different types of materials—such as PU and PET—mayrender greater durability and endurance to the valve assembly. Thismaterial is an alternative material to be used in the forging methodshown in FIG. 6.

FIGS. 14 to 14 c demonstrate the incorporation of heavy metal markers onthe stent, which markers allow observation and thereby adjustment oforientation while placing the device in the required location. Heavymetals are radiopaque, that is, they are conspicuous on an angioscopicimage, which is a two-dimensional image. Since the coronary artery ostia237 and 238 are located near the typical valve deployment location andmust stay open, it is extremely important to make sure that the deployedvalve assembly is not blocking a coronary ostium. In some cases thestent is lower than the ostium and in those cases it will stay open, butin some cases as shown in these figures it is necessary to make surethat the stent portion 239 that is connecting the valve supports 235 isopposite the coronary ostia, and in that way the blood supply ispreserved through the stent struts. Two heavy metal markers 232 areattached at the outlet side, one marker 230 at the inlet side. It ispossible to adjust the angiogscopic view to the plane of the leftcoronary as shown in FIG. 14 b and anatomically locate the otheraccordingly. If the two upper markers 232 are placed in the radiographictwo dimensional image, one on top of the other, and the low marker 230on the opposite side, we make sure that the coronaries are open to bloodflow as seen in FIG. 14 c. Gold, platinum, iridium or tantalum are allbiocompatible materials suitable for the markers described above.

FIGS. 15 a to 15 c illustrate a valve with a portion of radio-opaquematerial 267 such as a thread of gold at the sealing edge. When a valveis implanted, it is very important to have clear indications of how thevalve is functioning in vivo; pressure measurements, flow visualization,and doppler measurements are utilized. It is also possible to examinethe valve by ultrasound methods, however, observing the opening andclosing of the valve cusps on a monitor. FIG. 15 b is an angiographicimage 268 of the open valve, while image 169 in FIG. 15 c is the closedposition as seen on the angiogram.

FIGS. 16 a to 16 c illustrate a procedure, which helps in placing thedevice in the longitudinal position. It is very important to place thedevice in the correct longitudinal position, for if it is too deep inthe left ventricle it may interfere with the mitral valve function byimproper closing or function of the valve. If it is positioned too highit may migrate, it may leak via the sinus cavities, which are locatedaround it, and/or it may block the coronaries. It is a necessary task toposition the valve prosthesis in a narrow target location. In FIG. 14 amethod of lateral orientation placement is shown, and FIGS. 16 a to 16 cillustrate a longitudinal positioning. The valve device (the valveassembly and the support stent) is placed on an inflatable ballooncatheter, comprising double independently inflatable chambers 303, 305,and is inserted into the left ventricle 302 in the crimped position andguided over a guiding stylet or guide wire 300. The balloon, which islarger than the annulus diameter when inflated, is inflated in the leftventricle 302, and then the whole device is pulled slightly backwards.The balloon is supported on the inner part of the annulus 303, allowingpositioning of the device in the exact desired position. In addition, ittemporarily blocks the blood flow, and that improves the ability to holdthe device in place while inflating it. The next step is inflating thesecond balloon 305, which deploys the valve device in the desiredlocation.

The method for deploying an implantable prosthetic valve device at thenatural aortic valve position at the entrance to the left ventricle of amyocardium of a patient, as depicted in FIGS. 16 a, 16 b and 16 c,comprises the steps of:

(a) providing a balloon catheter having a proximal end and a distal end,having a first and second independently inflatable portions, the firstinflatable portion located at the distal end of the catheter and thesecond inflatable portion adjacently behind the first inflatableportion;

(b) providing a guiding tool for guiding the balloon catheter in thevasculature of the patient;

(c) providing a deployable implantable valve prosthesis device adaptedto be mounted on the second inflatable portion of the balloon catheter

(d) guiding the balloon catheter through the patient's aorta using theguiding tool, the valve device mounted over the second inflatableportion of the balloon catheter until the first inflatable portion ofthe balloon catheter is inserted into the left ventricle, whereas thesecond inflatable portion of the balloon catheter is positioned at thenatural aortic valve position;

(e) inflating the first inflatable portion of the balloon catheter so asto substantially block blood flow through the natural aortic valve andanchor the distal end of the balloon catheter in position;

(f) inflating the second inflatable portion of the balloon catheter soas to deploy the implantable prosthetic valve device in position at thenatural aortic valve position;

(g) deflating the first and second inflatable portions of the ballooncatheter; and

(h) retracting the balloon catheter and removing it from the patient'sbody.

FIGS. 17 a and 17 b describes a positioning of a valve device 310 usingan additional deployable stent 320. There are several problems that maybe encountered while deploying the stent and valve in the aortic valvelocation: blockage of coronaries may occur that is dangerous if thediameter of the stent is similar to that of the coronaries aortic root309. Secondly, migration of the whole device may also occur, which is adangerous possibility, and there is the problematic challenge of exactpositioning of the valve device that is very difficult to accomplish, asalready explained. The newly special designed device with a doublediameter inflatable balloon and double stent design allows placement ofthe device in a way that coronaries will not be blocked because of asafe difference that is kept between the diameters, longitudinal placingis less sensitive because of the small diameter which ensures preventsover expansion of the valved prosthesis. The distal stent 320, whichcontains no valve, is expanded into the ascending aorta, while theproximal stent 310 is placed simultaneously in the annular position.This placement method is less challenging due to the smaller diameter ofthe proximal stent 310 which ensures that the mitral valve is notdeformed by over-expansion as the dimensions are preserved, and theadditional stent decreases the risk of device migration. It is safer toover dilate in the aorta, which is not true for the annulus.

The method for deploying an implantable prosthetic valve device at thenatural aortic valve position at the entrance to the left ventricle of amyocardium of a patient, as depicted in FIGS. 17 a and 17 b, comprisesthe steps of:

(a) providing a balloon catheter having a proximal end and a distal end,having a first and second independently inflatable portions, the firstinflatable portion located at the distal end of the catheter and thesecond inflatable portion adjacently behind the first inflatableportion;

(b) providing a guiding tool for guiding the balloon catheter in thevasculature of the patient;

(c) providing a deployable implantable valve prosthesis device adaptedto be mounted on the first inflatable portion of the balloon catheter,and a deployable annular stent device adapted to be mounted over thesecond inflatable portion of the balloon catheter, the deployableimplantable valve prosthesis device and the deployable annular stentkept at a predetermined distant apart;

(d) guiding the balloon catheter through the patient's aorta using theguiding tool, the valve device mounted over the first inflatable portionof the balloon catheter and the deployable annular stent mounted overthe second inflatable portion of the balloon catheter, until the firstinflatable portion of the balloon catheter is positioned at the naturalaortic valve position;

(e) inflating the second inflatable portion of the balloon catheter sothat the deployable stent device is deployed within the aorta thusanchoring the deployable annular stent and the coupled valve device inposition;

(f) inflating the first inflatable portion of the balloon catheter so asto deploy the implantable prosthetic valve device in position at thenatural aortic valve position;

(g) deflating the first and second inflatable portions of the ballooncatheter; and

(h) retracting the balloon catheter and removing it from the patient'sbody.

FIGS. 18 a and 18 b illustrate an accessory crimping device that isadapted to crimp a valve device in the operating theater as part of theimplantation procedure. The crimping device 330 comprises severaladjustable plates that resemble a typical SLR camera variablerestrictor. It is comprised of simultaneously movable plates 332 eachprovided with a blade 334, that are equally dispersed in a radialsymmetry but each plate moves along a line passing off an opening in thecenter, all plates equidistant from that center opening 336. Initially(see FIG. 18 a) the plates are drawn apart providing a large enoughopening for the implantable valve to be positioned within that opening.When the plates are drawn towards the center (see FIG. 18 b), theopening 336 reduces in size but still retains the annular shape, andthis facilitates the crimping of the valve frame to a small dimensionsuitable for percutaneous positioning.

FIG. 19 a depicts a crimping method for the support stent of the valveprosthesis device of the present invention, whereby stent 340 iscrimped, that is, compressed or curled. In FIG. 19 b a crimping device343 is shown, comprising a body having an annular void in which anexpanded stent is positioned. Lever 346 is connected to the end 347 ofthe stent and as the lever is pulled the stent is curled or compressedabout axle 345 into a compressed position 349 (FIG. 19 c).

FIGS. 20 a and 20 b depict a valve made of a simple tube mounted to astent 352. During systole period the tube is fully open and duringdiastole period the tube collapses according to the mounting geometry357 and achieves sealing.

FIG. 21 describes a newly designed support stent 360 in its openposition. Three of the longitudinal struts 362 are full and thick andalways stay with their original constant size, serving as anchoringsupport. Each of these struts 362 is provided with a plurality of bores364, which are later used for mounting the valve assembly (not shown)and tying it to stent 360. Between struts 362 a web-like construction isprovided, which is capable of being crimped to a narrow state andcapable of being deployed again to a wider state.

FIG. 22 illustrates another preferred embodiment of an implantableprosthetic valve according to the present invention. It comprises ametal tube 370, having three portions with a thicker wall 371 than inthe rest of the tube 370, these areas form the longitudinal columns 372in the construction, after the tube is cut to its final form. Theadvantage of such a construction is in its superior bending strength, inspecific required portions of the construction, with minimalinterference to the crimped volume of the whole construction.

FIGS. 23 a to 23 c depict a new method of manufacturing an artificial orbiological crimpable valve device. A piece of fabric material 370 (FIG.23 a), is dipped in PU to create a portion which is later formed intovalve leaflets 371 (FIG. 23 b). This composite material 371 is thenattached to an additional piece of fabric such as PET 372 by means ofstitching, suturing or other attaching technique 373 (FIG. 23 c). Theresulting fabric 375 is cut along stitching line 373 leaving enoughmaterial to later suture the valve assembly to the support construction.It is then formed to a tubular shape and stitched 374 (FIG. 23 d). Thetubular valve is then attached to a support construction 380 by suturingthe bottom part around the valve 379 tightly to prevent leakage, andaround the cut fabric line 376 (FIG. 23 e). This open wall structure 378allows blood flow to the coronary arteries. The valve is later placedwith the coronary artery between the support columns 385. Additionalvariations of this can be made by replacing the composite material371/370 with a biological patch such as a suitable pericardium patch. Insome cases it is possible to make the same valve without cutting thefabric 372 with the shaped cut 376, and by that create a valve with anouter tubular shape. The embodiment of FIGS. 23 a to 23 c is easy tomanufacture as it is generally flat throughout most of the productionprocess and only at the final stage of mounting on the support stent isit given a three-dimensional form.

Reference is now made to FIG. 24 a illustrating a frame of animplantable prosthetic valve having means for mounting valve leaflets inaccordance with a preferred embodiment of the present invention that canform a tricuspid valve. FIG. 24 a depicts an isometric view of the frameand FIG. 24 b depicts a cross sectional view of the means for mountingvalve leaflets 430 in detail. A frame 420, which is suitable forcrimping and expanding, has three support beams 422 for mountingleaflets positioned substantially symmetrically about the circumferenceof the frame. Frame 420 is shown in FIG. 24 a in its deployed state.Support beam 422 has a “U” shaped lateral cross section, or profile(shown clearly in FIG. 24 b) that is designed to attach to a commissureof the valve structure. The “U” shape can be produced by extrusion, wirecutting or by welding the “U” profile to the frame's struts 421 atjunction points 424. Support beam 422 is provided with a series of bores425 positioned along its back wall. Bores 425 are designated forstitching the valve assembly by threads, wires, or other attachingmeans.

FIG. 24 b is a detailed cross-sectional view of one of the support beam422. Two pericardial leaflets 430 are inserted through a U-shaped, orforked holder 428 that compresses and restricts the leaflets in theU-shaped profile. Leaflets 430 are folded to both sides of the supportbeam 422. When holder 428 is compressed toward the support beam 422,leaflets 430 are caught in-between holder 428 and support beam 422 sothat the leaflets are kept in place. FIG. 24 c is an exploded view ofthe holder, bar 426 has a series of bores compatible for attachment tothe frames support beam 422, attachment being achieved by suture 423 orany other attachment means. This attachment method allows attaching theleaflets to the frame without puncturing it with sutures and needles. Itis also important that the leaflets are firmly held in place by theholder 428 so that it has no relative movement in respect to the rigidframe; hence avoiding wear due to movements. Leaflets that are made frompericardium are known to better withstand inner movements and stressesand less to wear by movement against rigid, hard or sharp bodies.

It is noted again that the entire valve structure is adapted to beradially crimped and radially expanded. This feature imparts the valvewith the ability and ease to navigate through narrow passages in thevasculature during positioning of the device. After final positioning ofthe valve, the valve is deployed. This is made possible by the provisionof a collapsible support frame structure. However, the length of theattaching means (the height of the valve) remains at all times constant;thus suitable for serving as the pliable valve assembly's anchorage. Theleaflets are attached to the support frame at the attaching means, anddue to their constant length there is no need for slack material asthese attachment points that remain at constant distances regardless ofthe position of the valve assembly (crimped or deployed). This is animportant feature for this means that the manufacturer of the valvedevice can make sure the valve assembly is secured and fastened to thesupport frame at all times. In prior art implantable valve devices, theentire support structure changes its dimensions from its initial firstcrimped position to final deployed position and this means that in theattachment of the valve leaflets to the support structure one must takeinto consideration these dimension changes and leave slack material sothat upon deployment of the device, the valve assembly does not tear ordeform. In the valve device of the present invention there is norelative movement between the valve leaflets and the support beams(along the longitudinal central axis of the device). As a result, thevalve device of the present invention acquires greater durability and iscapable of withstanding the harsh conditions prevailing within thevasculature and especially the millions of cycles of stress applied bythe blood pressure.

The fixed attachment of the valve leaflets to the support frame in thevalve assembly device of the present invention renders it greaterstability, enhanced safety, better sealing and consequently longerlifespan. The novel design of the valve device of the present inventionrenders it longitudinal strength and rigidity whereas its collapsiblesupport structure renders it radial flexibility.

FIGS. 25 a to 25 d illustrate an implantable prosthetic valve inaccordance with another preferred embodiment of the present invention.FIGS. 25 a and 25 b depict an isometric view and an upper view of thevalve assembly, respectively and FIGS. 25 c and 25 d illustrate upperviews of two optional constructions for the means for mounting leaflets.Pericardial leaflets 430 are mounted on a deployable support frame 432.The frame is preferably made of three segments that form a circularsupport frame when assembled (FIG. 25 b). Pericardial leaflets 430 areattached to deployable support frame 432 along three substantiallyequidistant and substantially parallel beams 440, which are integralparts of support frame 432. Leaflets 430 are attached to support frame32 at support beams 440 by suturing 446 leaflets 446 to support beams440 through bores 442 in beams. The frame segments that are preferablymade from stainless steel are pre-shaped 432 and can be formed indifferent ways. FIG. 25 c illustrates support frame segments 432 ahaving beams 435 a pointing inwardly. FIG. 25 d illustrates supportframe segments 432 b having beams 435 b that are outwardly pointing. Theadvantages of this technique are the possibility to manufacture theframe segments from sheets (as opposed to tube) and the ease of assemblyof the frame segments with the pericardial leaflets.

FIGS. 26 a to 26 c illustrate a tricuspid valve in accordance with yetanother preferred embodiment of the present invention, provided with aself-expandable frame. FIG. 26 a is an isometric view of an implantableprosthetic valve 430 mounted on a self-expandable frame 445. Implantableprosthetic valve 430 comprised of three valve leaflets is mounted onself-expandable frame 445 so that each leaflet extends along anequidistant portion of the frame and is sutured at both opposite sidesto substantially equidistant and substantially parallel beams 440. Byusing a tapered tube 448 the whole assembly is crimped into arestriction tube 449. FIG. 26 b shows the crimped valve assembly 447 inits final crimped diameter ready for insertion to the body. Afterinsertion into the desired location in the body the valve is releasedfrom the restriction tube and as it is made of self expandable material(like a shape-memory alloy), it expands back to the original diameterand is anchored in place. In order to reduce the diameter of the devicefrom its fully expanded diameter to its crimped diameter a specialtapered tube is used, shown in FIG. 26 c.

FIG. 27 illustrates an isometric view of an implantable prosthetic valvein accordance with another preferred embodiment of the present inventionhaving hooks designated to anchor the valve assembly to body ducts. Animplantable prosthetic valve 450 is placed in a natural aortic valveposition 452. Implantable prosthetic valve 450 comprises preferablythree leaflets 430 mounted on a metallic support frame 455. The lowerpart of support frame 455 is provided with attachment means, preferablywith hooks 453. Hooks 453 assures that the valve assembly stays in placeafter deployment, and cannot migrate to another position.

FIG. 28 illustrates a partial view of an implantable prosthetic valve inaccordance with yet another preferred embodiment of the presentinvention. The commissural attachment is shown in details. This figuredemonstrates an attachment technique that is used in order to attachpericardium leaflet 430 to a metallic frame 420. A longitudinal bar 456having a narrow slit 457 is used as the commissural attachment so thatextensions 463 of pericardium leaflet 430 are tightly inserted throughslit 457. Pericardium extensions 463 that are extended beyond slit 457are wrapped about a rigid bar 458 that acts as an anchoring means. Everytwo extensions originating from two sides of slit 457 are sutured toeach other by a suture 459 at the side of rigid bar 458 opposite theslit. An additional suture 462 attaches the bottom circumference ofsupport frame 420 to leaflet 420 in order to obtain sealing. Theadvantages of the described attachment are that no sutures or sutureholes are applied in the leaflet working area, there are no concentratedstress points similar to stress point caused by suturing, and the forcedistribution is along the longitudinal bar 456. The narrow passage thatis maintained through slit 457 forces the leaflets to be static inrespect to the support so as to reduce abrasion.

The embodiments that will be shown herein after are optionalconfigurations of attachment between the leaflets and the support frame.

FIGS. 29 a and 29 b illustrate an isometric view and an upper crosssectional view, respectively, of an attachment assembly of a valve'sframe to leaflets in accordance with a preferred embodiment of thepresent invention. The attachment is similar in principle to theattachment shown in FIG. 28, however, longitudinal bar 456 is furtherprovided with an additional pole 465 that is attached to longitudinalbar 456 so as to establish an integral part. Pole 465 is rounded so asto make sure the leaflets will not be abraded or cut by sharp corners.In the cross sectional view shown in FIG. 29 b, adjacent leaflets 460can be seen compressed together and the main protection goal is clearlyshown.

FIGS. 30 a to 30 c illustrate an isometric view, a cross-sectional viewand a flatten view, respectively, of an attachment assembly of a valvesframe to leaflets in accordance with another preferred embodiment of thepresent invention. Using the method demonstrated in FIGS. 30 a to 30 c,the pericardial leaflets are pre-cut to the desired shape 430 and areprovided with longitudinal bars 470 that are sutured to the leafletscreating a longitudinal clamping effect (FIG. 30 c). This allowsdistribution of forces along the whole length of the attachment means asopposed to concentrating the stresses in suture holes. In FIGS. 30 a and30 b, an additional rigid portion 458 is added, creating a round ending,which prevents the leaflets from being bent drastically at theattachment point to portions of the frame 420. The attachment to frame420 is performed using sutures 459.

FIGS. 31 a and 31 b illustrate an exploded view and an isometric view,respectively, of a commissural attachment in accordance with a preferredembodiment of the present invention depicting the attachment technique.A method of assembling pericardial leaflets 430 to a frame 420 isdemonstrated. A rigid bar 476 provided with integral protrusions 478 isinserted through bores 479 that are pre-cut in pericardial leaflets 430.Integral protrusions 478 pass through a sheet of preferably PET (braidedpolyester) fabric 475, and finally through bores 442 that are providedin longitudinal bar 440 (the attachment means) of frame 420. After theassembling of the parts, as shown in FIG. 31 b, the parts are tightlyassembled and bar protrusions 478 are attached to bar 440 by welding,riveting or any other technique. The PET sheet 475 is folded and suturedtightly around bar 476 using suture 472.

FIGS. 32 a to 32 c illustrate an isometric view of an attachment betweenleaflets and the frame in accordance with yet another preferredembodiment of the present invention. An optional method of attachment isdemonstrated, in which a pericardium leaflet 430 and bars 480 aresutured in an area as far as possible from the working area of theleaflets. The pericardium is first sutured using a suture 484 to bar 480as seen in FIG. 32 b, and then folded and compressed. In order to firmlyhold the pericardial leaflets in place between bars 480, an integralconnecting member 482 connects the two bars, allowing the bent portionsof the bars to be in parallel position, with the leaflets caught inbetween. Then, an additional suture 483 connects the bottom side of thebar to the leaflets so that while the valve is working, the leaflets donot bear high stresses.

FIGS. 33 a to 33 d illustrate different views of portions of anattachment between a pericardium and a frame in accordance with yetanother preferred embodiment of the present invention, demonstratinganother method of attachment in accordance with the preferredembodiment. A connecting member 490 (shown in a deployed position inFIG. 33 d) is used to connect two pericardial leaflets 492 at the lineof the commissurel. After being connected between them, pericardialleaflets 492 are being connected to frame bar 480. Here again, theprincipal of compressing the leaflets between two bent portions bars 491of connecting member 490 and tightening them using suture 484 withoutpunctures in the working areas of the pericardium is applied. However,connecting member 490 is provided with a portion 493 that is positionedperpendicular to the two bent portions bars 491 that holds the twoleaflets together. Portion 493 is the connecting member to frame's bar480. In FIG. 33 a, the junction point 495 between the portions ofconnecting member 491 is placed at the upper part (outlet) of the frameso as to achieve a rigid connection to the frame. In FIG. 33 b, junctionpoint 495 is placed at the bottom part (inlet) of the frame so that thejunction point also functions as a spring. Comprehensive explanation ofthe benefits of springs in commissures is discussed and shown in respectwith FIGS. 37 to 39.

FIGS. 34 a to 34 c illustrate an isometric view of an attachment betweena pericardium and a valve in accordance with yet another preferredembodiment of the present invention demonstrating another method ofattachment. In FIGS. 34 b and 34 c, a deployed portion and the foldedportion, respectively, are shown. An optional design for the attachmentbetween the frame and the leaflets is depicted. A connecting member 480(shown clearly in FIG. 34 b) is being produced into a flat configurationusing laser-cutting. Connecting member 480, which is a part of theframe's attachment means, is bent and then is ready for assembly withthe leaflets. Connecting member 480 comprises the main body as well as aconnection bar 497 and a flexible element 498 allowing flexibility tothe commissural. Leaflets 430 are threaded through corresponding holes481 in the structured connecting member 480 and are sutured using asuture 482.

Reference is now made to FIGS. 35 a, 35 b, and 35 c illustratingisometric and cross-sectional upper views, respectively, of attachmenttechniques between a pericardium leaflet and a valve's frame inaccordance with other preferred embodiments of the present invention.FIGS. 35 b and 35 c depict different techniques of commissuralattachments: in FIG. 35 b two pieces of pericardial leaflets 500 arewrapped around a metallic member 505 that is connected to a frame 501.Rigid members 503 are positioned from both sides of metallic member 505and then tightened together and connected by a suture 502. All metallicpieces are wrapped by PET fabric 508 in order to avoid direct contactbetween the metallic pieces and the delicate pericardial leaflets. Theadvantage of this structure is that after tightening the suture, thewhole commissure becomes static with no relative movement between theportions. This improves the valve assembly's resistance to abrasion. Inaddition, there are no needle holes or sutures in the working area. FIG.35 c depicts a similar structure, however, there is no use of rigidsidebars. After wrapping the metallic member 505 with pericardialleaflets 500, a piece of PET 508 is used for tightening it to a tightbundle. In this case, the suture line 502 is the borderline of theworking area so it should be designed so that stresses are in the bestpossible distribution.

FIGS. 36 a and 35 b focus on the connection of the commissural assemblyto frame's protrusion 509, which is an integral part of the frame and isthe basis for the commissural attachment. This example shows the use offour rigid longitudinal bars 503 connected by a suture 502.

FIGS. 37 a to 37 c illustrate a commissural assembly in accordance withanother preferred embodiment of the present invention, where theconnecting bar functions as a flexible support and has integralattachment means to the frame. FIG. 37 b is an isometric view of theconnecting bar. Connecting bar 520 is flexible and comprises a resilientmaterial shaped in a “U” shape. Connecting bar 520 is a part ofcommissural assembly 527 shown in FIG. 37 a. Connecting bar 520 isprovided with protruding elements 521 that are acting as the means ofattachment to the frame's bar 480. Protruding elements are designated tobe inserted in corresponding bores 442 in bar 480. It is optional toprovide rods 527 which are integral parts of the “U” shaped member andreplace the suture 526 that connects the pericardium leaflet and theconnecting bar together, which is shown in FIG. 37 a. FIG. 37 c depictsanother method of attaching the flexible connecting bar 520 to the frame480 by means of welding 523. Here the pericardial leaflets 500 areattached to the connecting bar 520 by suture 526 inserted through a PETfabric 508 and two connecting bars 503, which together create a tightbundle.

FIGS. 38 a to 38 g illustrate isometric views of flexible commissuralsupports and the method of attaching them to a pericardium and a frame avalve in accordance with preferred embodiments of the present invention.FIGS. 38 a to 38 c demonstrate incorporation of different design optionsof commissural springs. The main purpose of a commissural spring is toreduce the impact applied to the pericardial leaflets when the valveleaflets are closed. If the structure is of a rigid nature, high stresswill be applied each time the valve closes. If a spring is added to thestructure, the spring will bear the highest portion of the impact, thusreducing the stress applied to the leaflets during the time the valve isclosed. In FIG. 38 a, a simple stainless steel spring 530 is connectedto frame's bar 480 by threading a portion of the spring into slots 538as shown in more detail in FIGS. 38 e and 38 f. In FIG. 38 b, there is asimilar spring 530 with leaflets 500 connected to it by one of theattachment methods, the commissural support itself 530 is connected tothe frame's bar 480 by spot welding, laser welding or other attachmentmeans. FIG. 38 c depicts a similar spring 534 having an additionalspiral. The purpose of such a spiral is to reduce stress in the springand to allow the fatigue requirements, which in the case of heart valvesare of at least 200 million cycles.

FIG. 38 d illustrates an isometric view of a flexible commissuralsupport in accordance with yet another preferred embodiment of thepresent invention, demonstrating the attachment of the pericardium tothe support. FIGS. 38 e to 38 g are the details of the attachment to theframe. A commissural spring of a different design 539 comprises astainless steel wire of a small diameter in respect with the springsdescribed in FIGS. 38 a to 38 c. One advantage of this structure is thedistribution of stresses in the spring and the ability to form astructure, which can be crimped to a small diameter. Another advantagein this structure is that there are no open edges of the spring, whichcan be dangerous when operated; the open edges are protected in theframe's bar as shown in FIGS. 38 e to 38 g, which show possibleattachment methods of the spring to the frame. In FIG. 38 e, a frame'sflat bar 480 has slots 531 cut to form slot tabs 538 for crimping thespring 530. FIG. 38 f shows pre-bending of the slots 527 and FIG. 38 gshows the spring legs 539 assembled firmly into the slot tabs 538.

FIG. 39 a illustrates a technique of commissural assembly using a shapedcompressing member 511. The compression member 511 holds pericardialleaflets 500 firmly while pressing it in the pivot points 513. A radialedge 514 is made in order to protect the pericardium from abrasion. Thewhole assembly is held tightly inside the compressing member 516. Thecommissural assembly is connected to the frame by protrusion member 518,which fit bores in the frames bar 480. FIG. 39 b is an isometric view ofthe same detail.

FIGS. 40 a to 40 c illustrate an isometric view of a bicuspid valvemounted on a frame in accordance with yet another preferred embodimentof the present invention. FIGS. 40 b and 40 c depict a cross-sectionalside view and an isometric view, respectively, of the pericardium thatis sutured to a PET tube in the form of pockets. The valve assembly (inthis case bicuspid) comprises a crimpable frame 540, two pericardialleaflets 545, a PET skirt 543 and a connecting suture 547. The focus inthis drawing is on the pocket shape of the pericardium leaflet shownbest in FIGS. 40 b and 40 c. One of the main goals in valve design, ingeneral, is to distribute the stresses in a homogenous way in thepericardium material and the attachment areas. The design of thepericardium leaflet as a pocket assists in distributing the stressesalong suture line 547; pericardium leaflet 545 is sutured to PET skirt543 along connecting suture 547. PET skirt 543 is sutured to thecircumference of crimpable frame 540 at the bottom side 549 and at thetop 542 using one of the commissural attachments that are describedherein before regarding other embodiments. When hydrodynamic pressure isapplied on leaflets 545, the leaflets will meet in the center 546 offrame 540 so as to seal the valve assembly. The shape of the leaflets inthe valve assembly is determined by the boundary conditions, which inthis case are the suture lines. The suture lines can be designed to havean optimal shape regarding the stress distribution in accordance withgeometrical restrictions.

Reference is now made to FIGS. 41 a to 41 d illustrating isometric viewsof an implantable prosthesis tricuspid valve in accordance with yetanother preferred embodiment of the present invention. FIG. 41 aillustrates valve assembly 553 in an open state. Valve assembly 553comprises a frame 555 (rigid or crimpable), pericardial leaflets 550 andbars 551. It is emphasized that in the shown embodiment, the goal is todistribute the stresses on the commissural arrangement in an optimalway. Pericardial leaflets 550 are attached to bars 551 that act asattachment means. The attachment means are positioned at the top thirdof the valve; the bottom circumference is attached to the frame in orderto obtain full sealing. The middle part of the pericardium is leftslack. The pre-cut pericardium is cut in greater dimensions than theframe; e.g., the height of the pericardium leaflet is greater than theheight of the frame, for example, if the frame height is 15 mm, thepericardium will be cut to a height of 18 mm so as to establish a slackportion in the middle area of the valve assembly 553. FIG. 41 b depictsthe valve assembly in a closed state. The slack portion of thepericardium collapses toward the middle while creating a small pocketshape 554, which assists in the stress distribution. FIG. 41 c shows thedetailed commissural and the short bar attachment as well as thecircumference sealing area at the bottom portion of the pericardiumassembly. It is shown in the figures that bars 551, which are relativelyshort, allow firm attachment of the top portion of the commissural,slack portion in the middle, and a good sealing surface at the bottomportion 556.

Reference is now made to FIGS. 42 a and 42 b illustrating an isometricview of an implantable prosthetic valve in accordance with yet anotherpreferred embodiment of the present invention, having a differentcommissural attachment. FIG. 42 b depicts the attachment in details. Inthe embodiment shown in FIG. 42 a, similar valve assembly isillustrated, while the short bar is arranged in a manner that is similarto the structure shown in FIG. 28 and described herein before.Relatively short bars 559 act as the attachment means to the frame bar558. Suture 557 attaches short bars 559 to a member 558, the suture canbe made from an elastic material so that to add flexibility to thecommissures and to render the valve assembly the benefits alreadyexplained herein.

Reference is now made to FIGS. 43 a and 43 b illustrating an isometricview of an implantable prosthetic valve in accordance with yet anotherpreferred embodiment of the present invention. FIG. 43 a depictscommissures that are pre-sutured in a tapered shape. The valve assemblyshown in FIG. 43 a comprises a frame 560, pericardial leaflets 563, andattachment means 561. Pericardial leaflets 563 are shown to be in anopen state so as to establish an open valve assembly while dashed lines565 show the valve in a closed sealed state. The attachment to thecommissures can be performed using one of the explained techniques.Specifically to the embodiment shown in FIGS. 43 a and 43 b, the focusis on the formation of a tapered valve in which the attachment means isin the shape of long bars 561 that are attached to the pericardium in anangular way in apposition to the parallel attachment. Attaching the barsin an angular way when the pericardium is flattened will create atapered tube when built up to the three dimensional shape. When thewhole prosthetic valve is inflated by a balloon, the pericardiumleaflet, at the top circumference of the frame, is stretched and theframe is expanded to the full diameter. After deflating the balloon, theframe stays in its expended size but the pericardial leaflets regainstheir pre-stretched shape. This process creates a permanent clearancedistance 562 between the pericardial leaflets 563 and frame 560. This isof major importance in the protection of the pericardium from abradingagainst the frame.

Reference is now made to FIGS. 44 a to 44 c illustrating an isometricview of an implantable prosthetic valve in accordance with yet anotherpreferred embodiment of the present invention, with additional pieces ofPET used for sealing and protecting the pericardium. The illustratedimplantable valve assembly resembles the valve shown in FIG. 43,however, it is emphasized that in the attachment of the pericardialleaflets 570 to frame 575, there is use of PET. FIG. 44 c shows in across-sectional view, the way the PET is assembled to the pericardiumand the frame in a manner that protects the pericardium against wear.PET 571 and 572 are used for connecting pericardial leaflets 570 toframe 575, while they are assembled in between the leaflets and theframe. A suture 577 connects pericardium leaflet 570 in between twolayers of PET, while the inner layer of PET 572 is short and the outerlayer is longer. Bottom attachment suture 576, connects the threelayers, the leaflet and both PET layers to the frame and forms a strongsealing line. An upper suture 578 connects the outer PET layer 571 toframe 575. When the valve assembly closes and the pericardial leafletscome closer to each other at the top of the assembly, there is atendency of the bottom attachment to move and rotate about an attachmentpoint 577. Upper suture line 578 keeps the outer PET layer tight andprevents a part of this rotational movement, which can rapidly cause anabrasion failure.

FIGS. 45 a to 45 d illustrate an isometric view of an implantableprosthetic valve in accordance with yet another preferred embodiment ofthe present invention, having leaflets sutured to a pre-shaped PET tubeand optional leaflet-tube attachments in details. A novel technique ofmounting pericardial leaflets 580 to a pre shaped PET tube 585 is shown.The tube is shaped so as to have a folding 586 with substantiallysinusoid pattern 586 that is similar to the optimal connection line ofvalve leaflets in the natural valve. This shape allows the pericardialleaflets to be sutured to the interior of the PET tube. The preferredsuturing techniques are shown in the cross sectional views of PET tubesin FIGS. 45 b, 45 c, and 45 d. Generally, in order to protect thepericardial leaflets from tearing, an additional piece 583 of PET isadded below the suture lines. Similar variations are shown in FIGS. 45 cand 45 d.

Reference is now made to FIG. 46 a illustrating an exploded view of animplantable prosthetic valve assembly in accordance with yet anotherpreferred embodiment of the present invention, where the leaflets aremounted on a pre-cut and pre-shaped tube and the outlet of the valve iscut in a commissural shape. FIG. 46 a is view of the attachment. Apre-shaped PET tube 590 is cut to have substantially sinusoidal shape596 and then bent in order to provide a suturing area. The pericardiumleaflet 593 is pre-cut and assembled to PET tube 590 by means ofsuturing 502. In this case as well as in the former case, an additionalprotective layer of PET or pericardium 594 is added. FIG. 46 b is across-section of the attachment detail after being tightened

FIGS. 47 a to 47 c illustrate a partial cross-sectional side view of aninflating balloon in accordance with a preferred embodiment of thepresent invention. The balloon is a part of an implantable prostheticvalve delivery system. FIGS. 47 b and 47 c are cross sectional upperviews in the inflated and deflated positions, respectively. Thespecially designed balloon shown in the figures preferably comprisesfour inflating members, three substantially identical and symmetricalsections 600 and a central section 602. Pericardial leaflets 612 arepositioned between sections 600 and separate them. A frame 610 circlesthe inflating members and a balloon shaft 619 that is positioned in thecenter of the delivery system while a commissural connection 613connects pericardial leaflets 612 to frame 610. The inflated balloonsections 600 are placed between frame 610 and pericardial leaflets 612so that when the inflating members are inflated, they push leaflets 612toward each other and frame 610 so as to establish a fully closedposition. This technique better preserves the leaflets since there is nocontact between the leaflets and the frame besides in the commissuralconnection. The preservation of the leaflets is even improved in timesof inflation as well as after inflating the valve and establishing aclosed position. In FIG. 47 a the fourth inflating member of theballoon, central section 602 is clearly shown. Through central section602, the inlet 617 of the valve is inflated while the inflated centralsection assures that the whole valve is fully inflated to substantiallyround shape. FIG. 47 c shows the assembly in a crimped position. Frame610 is crimped and sections 600 are deflated. Pericardial leaflets 612are also shown in a crimped configuration.

FIGS. 48 a and 48 b illustrate a partial cross-sectional side view andan upper cross sectional view of an inflating balloon in accordance withanother preferred embodiment of the present invention. The inflatingballoon comprises of a central inflating balloon 620 and threeprotection sheets 622. In the lateral cross-section shown in FIG. 48 b,the parts of inflated assembly 625 are clearly shown, protection sheets622 protects the pericardial leaflets 624 from being pushed against theframe 625 when the device is inflated. The advantage of this arrangementis in the protection of the pericardial leaflets.

The preferred embodiments representing an implantable prosthetic valvein accordance with the present invention are relatively easy tomanufacture as they are generally flat throughout most of the productionprocess and only at the final stage of mounting the other elements ofthe valve assembly on the support frame, a three dimensional form isestablished.

A typical size of an aortic prosthetic valve is from about 19 to about25 mm in diameter. A maximal size of a catheter inserted into thefemoral artery should be no more than 8 mm in diameter. The presentinvention introduces a device, which has the ability to change itsdiameter from about 4 mm to about 25 mm. Artificial valves are not new;however, artificial valves in accordance with the present inventionposses the ability to change shape and size for the purpose of deliveryand as such are novel. These newly designed valves require newmanufacturing methods and technical inventions and improvements, some ofwhich were described herein.

As mentioned earlier, the material of which the valve is made from canbe either biological or artificial. In any case new technologies areneeded to create such a valve.

To attach the valve to the body, the blood vessels determine the sizeduring delivery, and the requirements for it to work efficiently, thereis a need to mount it on a collapsible construction which can be crimpedto a small size, be expanded to a larger size, and be strong enough toact as a support for the valve function. This construction, which is insomewhat similar to a large “stent”, can be made of different materialssuch as Nitinol, biocompatible stainless steel, polymeric material or acombination of all. Special requirement for the stent are a subject ofsome of the embodiments discussed herein.

The mounting of the valve onto a collapsible stent is a new field ofproblems. New solutions to this problem are described herein.

Another major aspect of the design of the valve of the present inventionis the attachment to the body.

In the traditional procedure the valve is sutured in place by acomplicated suturing procedure. In the case of the percutaneousprocedure there is no direct access to the implantation site thereforedifferent attachment techniques are needed.

Another new problem that is dealt herein is the delivery procedure,which is new and unique. Positioning of the device in the body in anaccurate location and orientation requires special marking and measuringmethods of the device and surgical site as was disclosed herein.

Artificial polymer valves require special treatment and specialconditions when kept on a shelf, as well as a special sterilizationprocedure. One of the consequences of the shelf treatment is the need tocrimp the valve during the implantation procedure. A series of devicesand inventions to allow the crimping procedure are disclosed herein.

It should be clear that the description of the embodiments and attachedFigures set forth in this specification serves only for a betterunderstanding of the invention, without limiting its scope as covered bythe following claims.

It should also be clear that a person skilled in the art, after readingthe present specification could make adjustments or amendments to theattached Figures and above described embodiments that would still becovered by the following claims.

What is claimed is:
 1. A prosthetic heart valve, comprising: a radially collapsible and expandable annular support frame; three pairs of parallel support bars, each pair of parallel support bars mounted radially inwardly of the support frame, each support bar provided with a plurality of preformed bores; and a valve assembly comprising three pericardial leaflets, the valve assembly anchored within the support frame at least in part by stitching that extends through the pericardial leaflets and through the bores of the support bars; wherein a gap is provided between each pair of parallel support bars through which a respective pair of adjacent end portions of the pericardial leaflets extend.
 2. The prosthetic heart valve of claim 1, wherein each end portion of each pericardial leaflet wraps at least partially around one of the support bars.
 3. The prosthetic heart valve of claim 2, wherein each pair of end portions of the pericardial leaflets is compressed between the support bars of a respective pair of support bars.
 4. The prosthetic heart valve of claim 3, wherein each end portion of each pericardial leaflet extends circumferentially between an inner surface of the support frame and a respective support bar.
 5. The prosthetic heart valve of claim 1, wherein each pair of support bars is connected to the support frame by a connecting member.
 6. The prosthetic heart valve of claim 1, wherein each connecting member is located adjacent an outlet end of the support frame.
 7. The prosthetic heart valve of claim 1, wherein the preformed bores extend through the support bars in a circumferential direction.
 8. The prosthetic heart valve of claim 7, wherein the circumferentially extending bores in each pair of support bars are aligned.
 9. The prosthetic heart valve of claim 1, wherein a clearance distance is provided between each pericardial leaflet and an outlet portion of the support frame for protecting the pericardial leaflets from abrasion against the support frame.
 10. The prosthetic heart valve of claim 9, wherein an outlet of the valve assembly is tapered with respect to an inlet of the valve assembly.
 11. The prosthetic heart valve of claim 1, wherein an inlet of the valve assembly is sutured to an inlet end of support frame.
 12. The prosthetic heart valve of claim 1, wherein the support bars are not co-extensive with a height of the support frame.
 13. The prosthetic heart valve of claim 12, wherein the support bars extend only along an outlet end portion of the support frame.
 14. A prosthetic heart valve, comprising: an annular support frame that is radially collapsible and radially expandable; a plurality of longitudinal support bars of fixed length, each support bar mounted radially inwardly of the support frame, each support bar provided with a plurality of preformed bores along the length thereof, each of the preformed bores extending in a circumferential direction; and a valve assembly comprising a tubular conduit having an inlet and an outlet, the conduit anchored within the annular support frame at least in part by stitching extending through the valve assembly and the bores of the support bars; whereby, when flow is allowed to pass through the conduit from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as collapsible slack portions of the valve assembly between the support bars collapse inwardly providing blockage to the reverse flow.
 15. The prosthetic heart valve of claim 14, wherein the conduit comprises a plurality of leaflets each comprising opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures that are secured to the support bars by the stitching.
 16. The prosthetic heart valve of claim 15, wherein the support bars comprise three pairs of support bars located at the commissures, each pair of adjacent end portions of the leaflets extending between the support bars of a respective pair of support bars.
 17. The prosthetic heart valve of claim 16, wherein for each pair of adjacent end portions of the leaflets, one end portion is folded at least partially around and stitched to one of the support bars of the respective pair of support bars and the other end portion is folded at least partially around and stitched to the other support bar of the respective pair of support bars.
 18. The prosthetic heart valve of claim 17, wherein each commissure is secured to a respective pair of support bars by stitching that extends through a first layer of one end portion of a leaflet, through the openings of one of the support bars, through a second layer of the one end portion of the leaflet, through a first layer of the end portion of the other leaflet, through the openings of the other support bar, and through a second layer of the end portion of the other leaflet, in that order.
 19. A prosthetic heart valve, comprising: a collapsible and expandable annular support frame; a plurality of circumferentially spaced, commissure connecting members coupled to the support frame, each commissure connecting member comprising a pair of longitudinal support bars, each support bar provided with a plurality of preformed bores along a length thereof, and each support bar positioned radially inwardly of the support frame; and a valve assembly comprising pericardial tissue and forming three leaflets, each leaflet comprising opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures, each commissure extending radially between the support bars of a respective pair of support bars, each commissure secured to a respective pair of support bars by stitching that extends through the bores of the support bars and the end portions of the leaflets.
 20. The prosthetic heart valve of claim 19, further comprising stitching securing each connecting member to the support frame. 